# K191257: Erchonia EVRL

- Pathway: 510(k) (Traditional)
- Applicant: Erchonia Corporation
- Decided: Aug 8, 2019 after 90 days
- Product code: NHN (Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K152196 (2016). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152196: Erchonia EVRL, Erchonia Corporation (2016) Summary page 4.

## Most influential descendants
- K251903: Erchonia DPN Laser (Model# EVRL) (2026), 0 descendants of its own
- K221987: Erchonia GVL (2022), 0 descendants of its own

## Indications for use
The Erchonia® EVRL laser is generally indicated: a. while using the red and violet diode simultaneously, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin, b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.

Source page: https://510kreport.com/device/K191257
Methodology: https://510kreport.com/methodology